In cases with no significant change in patient angina, how is it possible to ensure therapy was provided as it does not have an immediate effect?
One should distinguish between technical and operational malfunction and unfavorable patient characteristics when analyzing the results. In order to reduce the chance for a malfunction, the user has to make sure the following: The shockwaves are generating sound when triggered. No presence of air bubble inside the SWA. The SWA was used within its guaranteed […]
How can I know if the improvement in perfusion is the result of the therapeutic stimulated angiogenesis or due to the natural angiogenesis process in ischemic tissues?
Several results could confirm that the effect is true therapy and not “placebo” effect. ESMR improved myocardial perfusion only in the region where SW’s were applied. Ischemic areas not treated stayed ischemic. Patients treated have chronic stable angina class III or IV without change prior to treatment. In vivo controlled studies confirm the significant increase […]
Is there a change in the medication after treatment?
Yes. There is a reduction of at least 85% in the weekly intake of nitrates after treatment.
Is there a need for special post treatment procedures?
No, but if needed, it is recommended to monitor cardiac enzymes and controlled ECG. All showed negative in the studies performed.
Is it possible to undertake repeated sessions?
Yes. Shock waves could be delivered as long as there is a clinical need for collaterals development.
Are there any side effects?
No. There were no reports of side effects during, immediately after or post treatment. There was no pain associated and no signs of local hemorrhage. Vital parameters, cardiac enzymes and ECG were unchanged. In addition, there was no indication of arrhythmias and new wall motion abnormalities.
What does the patient feel during treatment?
The patient sometimes feels a tickling sensation in the chest during treatment. Some patients feel dizziness. All these effects pass immediate or shortly after the treatment is stopped.
Can I see the treatment site during delivery of shock waves?
Yes. There is no need to move the ultra-sound probe during treatment. Shock waves can be delivered safely with real-time view of the treatment site.
What should I do if the patient has extrasystole?
The Cardiospec is equipped with two modes for delivering shock waves. Automatic mode and Manual mode. When the patient has a history of ventricle extrasystole, the Cardiospec should be in Manual mode, thus, delivery of shockwaves using the Remote control by the user. When the E.C.G. monitor shows an extrasystole then the user should delay […]
Do shock waves cause arrhythmias?
No. The delivery of shock waves is synchronized with the patient’s R-wave. During this period, the heart is in its refractory phase, thus, another action potential cannot be produced eliminating the risk for arrhythmia. The synchronization serves another purpose as well, as a means for precision in delivery of treatment as the heart will be […]
Why was this protocol chosen?
This protocol was chosen in order to maximize the effect of shock waves on the development of collaterals. Collaterals develop usually within 2-3 weeks, which is the reason for the chosen intervals between treatments. In addition, animal studies found that maximal expression of angiogenic factors occur after 4 weeks. Also, clinical data, evaluating therapy on […]
Is there a need for special pre-treatment procedure?
Patients should be at the maximum tolerable dose of two or more antianginal drugs for at least 6 weeks prior to treatment. Also, anti-coagulation medication should be monitored.
How soon after PCI/CABG can the patient undergo a shock wave therapy?
As soon as the patient is stabilized (including hemodynamic stability), it is possible to start shockwave therapy.
Is it possible to use shock wave therapy on patients with pacemakers?
Yes. It is possible, as shock waves are delivered during the R-wave. Also, safety tests have demonstrated no effect of shock-waves on the function of the pacemakers.
Is it possible to use shock wave therapy after PCI/CABG?
Yes. It is possible if the patient has a proven ischemic zone.
I have heard that the shock wave applicator (lithotripter) in the urology department is noisy and there is a need to wear ear protection. Is it required during cardiac applications?
No. Unlike urologic applications, Cardiac shock wave therapy requires less powerful shock waves (1/10th of Lithotripsy). For that reason the Cardiospec is fitted with a smaller generator, producing less intense electrical sparks thus generating significantly less noise. There is no need to wear ear protection during treatment.
Is it necessary to hospitalize the patient?
No. Although no side effects were reported so far, patients at high risk (poor hemodynamic conditions) are recommended to stay in the hospital for monitoring following the treatment.
What are important precautions with regard to Cardiospec treatment?
The candidates of this treatment are usually taking anti-aggregates on a regular basis. There is no treatment limitation in patients treated with Aspirin or Clopidgrel. The treating physician should take into consideration the bleeding tendency resulting from their intake and might consider changing anticoagulant regimen prior to shock wave treatment to prevent local hematoma. In […]
What are the exclusion criteria for treatment?
Patients with the following conditions (selected list): Patients with intracardiac Thrombus Patients with malignancy at the area of treatment Pulmonary disease (emphysema) that blocks the acoustic window Pregnancy
What is the inclusion criteria for treatment?
Patients with documented myocardial ischemia not eligible for “conventional” treatment such as PCI or CABG or has Refractory Angina (Incomplete revascularization, CABG/PTCA failure, Disease progression in native coronary arteries, inadequate treatment of concomitant diseases (eg, hypertension), Microvascular dysfunction). Patient should have angina or angina equivalent symptoms prior to therapy. Therapy had higher success rate the […]
Who can use the Cardiospec?
The Cardiospec should be used by an echocardiography specialist. This could be a cardiologist or an echo technician supervised by the cardiologist who determined the course of treatment. All users should undergo training by Medispec or its local authorized representative to operate the Cardiospec.
